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All Journal Journal of Applied Pharmaceutical Research
Vikhe, Akshay
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Medicine & Pharmacology

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Development and validation of a QbD-based RP-HPLC method for vericiguat quantification Mandhare, Shubham; Godge, Rahul; Vikhe, Akshay; Talole, Shubham
Journal of Applied Pharmaceutical Research Vol. 12 No. 2 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.18231/j.joapr.2024.12.2.57.67

Abstract

Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temperature, the flow rate was 0.8ml/min, and the wavelength was 331nm. The results indicated that the quantification limit was 0.7209 µg/ml, and the detection limit was 0.2379 µg/ml. Conclusion: The validation studies confirmed that the developed method is fast, accurate, precise, cost-effective, selective, and useful for routine analysis of vericiguat in tablet dosage forms.
Design, development, and optimization of mucoadhesive buccal films of ganaxolone for enhanced bioavailability Pawar, Onkar; Godge, Rahul; Shinde, Ganesh; Barde, Kailas; Vikhe, Akshay
Journal of Applied Pharmaceutical Research Vol. 13 No. 2 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i2.943

Abstract

Background: CDD disorder affects children mainly during their first three months of life. The buccal route offers advantages over oral administration for ganaxolone by avoiding first-pass metabolism and providing direct systemic absorption. This study aimed to formulate and characterise mucoadhesive buccal films of ganaxolone to increase its bioavailability. Methods: Mucoadhesive buccal films were prepared using a solvent casting technique employing HPMC K4M and Moringa gum as polymers. The formulation was optimized using a 32-factorial design, where polymer concentrations were varied systematically to achieve optimal film properties. Nine batches (OF1-OF9) were formulated and evaluated for various physicochemical parameters, mucoadhesive strength, percentage drug content, goat buccal mucosa permeation study, and stability analysis. Results: Based on the findings, the OF8 batch containing optimal polymer ratio (250mg HPMC K4M and 60mg Moringa gum) emerged as the superior formulation with 94.45±0.34% drug content, 15.37±0.58 N/mm² tensile strength, and 7.8±0.57 N mucoadhesive strength. Permeation studies consequently confirmed 96.37% of the drug at 8 hours with a 13.63 µg /cm² /h permeation rate. There was no evidence of drug-excipient interaction in FTIR and DSC analysis. The formulation was set to be stable for 6 months at accelerated conditions (40±2°C, 75±5% RH) with an average tensile strength above 15 N/mm² and an average ex-vivo drug permeation of 93%. Conclusion: This optimized buccal film formulation demonstrates promising potential for clinical application in CDD treatment by offering enhanced bioavailability, controlled release, and patient-friendly administration, which is particularly beneficial for pediatric patients.
Co-Authors Barde, Kailas Godge, Rahul Mandhare, Shubham Pawar, Onkar Shinde, Ganesh Talole, Shubham